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Single Dose PG102 in Patients With Active Psoriatic Arthritis

This study has been terminated.
(poor recruitment)
Sponsor:
Information provided by:
PanGenetics UK Limited
ClinicalTrials.gov Identifier:
NCT00787137
First received: November 6, 2008
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves around the body and to explore its effects on the disease.


Condition Intervention Phase
Arthritis, Psoriatic
Drug: PG102
Drug: Placebo comparator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With Active Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by PanGenetics UK Limited:

Primary Outcome Measures:
  • The Number of Reported Adverse Events [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    This was an exploratory study and all safety endpoints were considered.

  • The Percentage of Participants With Adverse Events [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
  • The Number of Episodes of Change in Vital Signs [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing. The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.

  • The Number of Episodes of Change in Electrocardiogram [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose. The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.

  • The Number of Episodes of Change From Screening in Laboratory Assessments [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.


Enrollment: 17
Study Start Date: December 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PG102 0.3 mg/kg
Lowest dose PG102
Drug: PG102
A single intravenous infusion
Other Name: Anti-CD40 monoclonal antibody
Experimental: PG102 1 mg/kg
Second dose PG102
Drug: PG102
A single intravenous infusion
Other Name: Anti-CD40 monoclonal antibody
Placebo Comparator: Placebo (phosphate-buffered saline)
Control
Drug: Placebo comparator
Phosphate-buffered saline

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
  • Plaque psoriasis for at least 6 months prior to study enrollment

Exclusion Criteria:

  • Clinically significant psoriasis flare
  • Unstable doses of pain relief medication
  • Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
  • Treatment with any biologic therapy
  • Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
  • Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers
  • Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event
  • Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI
  • Currently smoking ≥ 10 cigarettes per day or equivalent
  • Active tuberculosis or other infection
  • Current or previous malignancies
  • Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787137

Locations
Serbia
Professor Nemanja Damjanov
Belgrade, Serbia
Sponsors and Collaborators
PanGenetics UK Limited
Investigators
Principal Investigator: Nemanja Damjanov, MD PhD Institute of Rheumatology, Belgrade, Serbia
  More Information

No publications provided

Responsible Party: John Powell, PanGenetics UK Limited
ClinicalTrials.gov Identifier: NCT00787137     History of Changes
Other Study ID Numbers: PG102-01, 2007-001017-42
Study First Received: November 6, 2008
Results First Received: August 12, 2010
Last Updated: October 15, 2010
Health Authority: Serbia: Agency for Medicines and Medical Devices
Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014